Compliance in the Life science Industry

The GMP simply stipulates that GxP manufacturers must have GxP partners. This short sentence shows that the potential partnership is clearly linked to the compliance concerns.

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What is a compliant partner? How to recognize and qualify it?

 

First of all, the compliance is one of the first concern for the life science industry. This is a permanent challenge, more and more complex due to the increasing number of laws and recommendations.

 

A partner has to be able to provide compliant process solutions by having the following :
 
approach including de facto the key regulatory based on the FDA requirements, on the Code of Federal Regulation, on the most universal guidelines (Good Practices)
a compliant QA system (validation Master Plan and White paper) have to be available
a global approach but a local presence
trained employees (basic and advanced GxP, project management, documentation management, calibration)
long experience on the processes and capabilities to "tune" the selection of the measuring instruments which fit
improve the documentation (IQ - OQ -PQ) and reporting
 sharing knowledge
contributing to costs savings, including in the maintenance
abitility to debate on the process's uncertainities
implementing the new technologies
the "V" model as reference for all the guidelines
belonging as active memner in the most important worldwide associations recognized by the pharmaceutical industry
having a global offering which fits to the market's expectations, including not only instruments for the process but also the ability to participate to the projects teams for consultancy aspects, having a broad offering in the services (DQ IQ OQ PQ) as well as global solutions
 

Finally, compliant partners allows the life science industry to concentrate on its core business (pioneering reaserch and development) while reducing their costs and increasing service.
 
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